Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Composite primary end-point of any access related complication
研究概览
简要总结
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 60 and higher
- •CCI Score >6 when under 60 years
- •Patients with CKD G5 A1-3 with indication for hemodialysis
- •Stable clinical condition
- •Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
- •Availability for follow-up.
- •Written informed consent.
排除标准
- •Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening.
- •Poor general condition of health or malignancy not in remission at screening
- •Major surgery within 12 weeks before screening.
- •Pre-existent vascular access.
- •Patient not eligible for any one of the vascular access options.
研究组 & 干预措施
Arteriovenous fistula
干预措施: Arteriovenous Fistula (Device)
Tunneled Cuffed Catheter
干预措施: Tunneled Cuffed Catheter (Device)
结局指标
主要结局
Composite primary end-point of any access related complication
时间窗: From placement of vascular access through study completion, an average of 3 years.
Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
次要结局
未报告次要终点
研究者
Guerkan SENGOELGE
Assoc. Prof. Priv.-Doz. Dr.
Medical University of Vienna
